Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT02404233
Eligibility Criteria:
Inclusion Criteria:
1. HIV-1 RNA ≥ 5000 copies/mL by PCR
2. ≥ 18 years of age
3. Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol
4. Less than 7 days of prior ART with any licensed or investigational compound
5. Patient does not currently have or has not been treated for an active opportunistic infection (OI) consistent with CDC definition (Appendix C) within 30 days of screening
6. Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
7. A female is eligible to enter and participate in this study if she is of non child bearing potential or child bearing potential, has a negative serum pregnancy test at screen.
Exclusion Criteria
1. Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
2. Patient has none of the following darunavir-associated RAMs: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V
3. Having documented genotypic evidence of NNRTI resistance at screening or from historical data available in the source documents, i.e. at least one of the NNRTI rams from the following list; K101E, K101P, E138A, E138G, E138K, E138R, E138Q, , V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, M230L, or the combination of the K103N and L100I.
4. History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments.
5. Patient is either pregnant at time of screening evaluation or breast-feeding.
6. Patient, in the opinion of the investigator, is unlikely to be able to complete the 48-week dosing period and protocol evaluations and assessments or adhere to the study drug regimen.
7. Patient suffers from a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the patient
8. Patient has malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication.
9. Patient is undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial
10. HBV co-infection
11. Patient has any of the following laboratory results within 30 days prior to the first dose of study medication:
* Hemoglobin concentration \< 8.0 g/dL
* Absolute neutrophil count \< 750 cells/mm3
* Platelet count \<50,000 cells/ mm3
* Aminotransferase (AST, ALT) \>3 times ULN
* Serum creatinine \>1.5 times the Upper Limits of Normal (ULN)
12. Patients with severe hepatic impairment
13. Patient has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02404233
Study Brief:
Protocol Section:
NCT02404233